Stroke is an important cause of perioperative morbidity and mortality, particularly in patients > 60 years. In cardiac, neurological and carotid surgery the incidence is known to be high (2.2-5.2%). However, little is known regarding perioperative stroke following other types of surgery including general, urological, orthopedic, thoracic and gynecological procedures. We therefore propose to undertake a multicenter, observational cohort study, to determine the current incidence of, the risk factors for, and outcome associated with perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.

Multi-center Prospective Investigation of Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries and Practicability of NIHSS in Screening Peri-operative Strokes

Further study details as provided by Chinese Medical Association:

Primary Outcome Measures:

perioperative stroke occurs during and within 30 days after surgery. [ Time Frame: 30 days after suegery ] [ Designated as safety issue: No ]

The primary outcome is perioperative stroke occurs during and within 30 days after surgery. This is defined as cerebral infarction or hemorrhage on computer tomography or magnetic resonance scan, or new neurological signs (paralysis, weakness or speech difficulties) lasting more than 24 hours or leading to death. The mechanism of stroke will be classified using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria.

Secondary Outcome Measures:

total mortality and other major vascular complications up until 30 days after surgery [ Time Frame: 30 days after suegery ] [ Designated as safety issue: No ]

Secondary outcomes include total mortality and other major vascular complications up until 30 days after surgery:

Myocardial infarction is defined according to recent universal definition of myocardial infarction;

Nonfatal cardiac arrest is a successful resuscitation from either documented or presumed ventricular fibrillation or sustained ventricular tachycardia or asystole;

Pulmonary embolism;

Congestive heart failure is defined by both clinical and radiographic evidence;

Cardiac death: defined as any death with a cardiovascular cause, including deaths following a cardiovascular procedure, cardiac arrest, myocardial infarction, pulmonary embolus, stroke, hemorrhage, or deaths due to unknown cause.

Monitoring, follow-up, and data collection: Usual treatment will be provided. Demographic details will be recorded. Patients will be visited regularly in hospital. Patient will be reviewed for neurologic deficit using the mNIHSS. Brain imaging will be performed to confirm stroke event. Follow-up at 30 days after discharge will be done to ascertain if there is any adverse outcome.

Eligibility

Ages Eligible for Study:

60 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

We propose a sample size of 10,000 patients to ensure a stable logistic model for an anticipated stroke rate of 1.0%.

Criteria

Inclusion Criteria:

Ages Eligible for Study: 60 Years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Sampling Method: Probability Sample

Exclusion Criteria:

hospital stay after surgery less than 3 days

not consent of the assessment

surgery canceled

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01758952